QA Specialist

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The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is part of the quality assurance department in Israel and reports to the QA Team Leader. The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is responsible for quality activities related to all products manufactured and/or processed by the Israel sites whether for research or applied (ISO 13485).

KEY TASKS & RESPONSIBILITIES

Ensuring adequate Quality System in customer facing activities in place
Ensuring adequate Quality System in place within internal quality assurance activities
Ensuring ISO-9001, ISO 13485 requirements, are implemented as applicable.
Supporting the Quality issues towards in- house as well as external customers.

AUTHORITY

Supporting Technical Service department for questions/complaints on products manufactured locally
Communication with customers and customer service units, initiating and follow up on SCAR were applicable.
Monitor complaints status: reports, trends, deviations, CAPA, change control etc.
Control of change
Handling of deviations
Initiate, create and review relevant SOPs in the Documentation system (Procedures, Manufacturing Protocols, Specifications)
Presenting Sigma-Aldrich Israel Quality system to customers (internal and external) when required
Management and completion of product shelf-life stability studies according to the local implementation requirements
Write stability protocols and reports. Initiate, track, and monitor stability studies. Ensure all stability study failures are investigated.
Perform QA shop floor inspections in the production and packaging departments
Perform other duties and responsibilities assigned by the QA Team Leader or Head of Quality.

MAIN INTERFACES

INTERNALLY:

Production, QC, Engineering, Maintenance, Warehouse and R&D departments.

EXTERNALLY:

Services Suppliers

QUALIFICATIONS

EDUCATION/LANGUAGES
Academic Degree (Bsc.) in Natural Sciences or Engineering (Chemistry, Biochemistry, Biotechnology or Microbiology).
English: Technical (read/written/spoken)

PROFESSIONAL SKILLS & EXPERIENCE

Previous industrial experience in ISO 13485 is an advantage.
Previous experience in a computerized environment.
Proficient Microsoft Office applications including Word, Power Point and Excel.

PERSONAL SKILLS & COMPETENCIES

Energetic and able to work in dynamic environments.
Strong problem solving and analytical skills.
Fluency in both written and spoken English.
Excellent communication skills
Good ability to work in teams
Multitasking and time management abilities
Detail oriented, excellent organizational and planning skills.
The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is part of the quality assurance department in Israel and reports to the QA Team Leader. The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is responsible for quality activities related to all products manufactured and/or processed by the Israel sites whether for research or applied (ISO 13485).

KEY TASKS & RESPONSIBILITIES

Ensuring adequate Quality System in customer facing activities in place
Ensuring adequate Quality System in place within internal quality assurance activities
Ensuring ISO-9001, ISO 13485 requirements, are implemented as applicable.
Supporting the Quality issues towards in- house as well as external customers.

AUTHORITY

Supporting Technical Service department for questions/complaints on products manufactured locally
Communication with customers and customer service units, initiating and follow up on SCAR were applicable.
Monitor complaints status: reports, trends, deviations, CAPA, change control etc.
Control of change
Handling of deviations
Initiate, create and review relevant SOPs in the Documentation system (Procedures, Manufacturing Protocols, Specifications)
Presenting Sigma-Aldrich Israel Quality system to customers (internal and external) when required
Management and completion of product shelf-life stability studies according to the local implementation requirements
Write stability protocols and reports. Initiate, track, and monitor stability studies. Ensure all stability study failures are investigated.
Perform QA shop floor inspections in the production and packaging departments
Perform other duties and responsibilities assigned by the QA Team Leader or Head of Quality.

MAIN INTERFACES

INTERNALLY:

Production, QC, Engineering, Maintenance, Warehouse and R&D departments.

EXTERNALLY:

Services Suppliers

QUALIFICATIONS

EDUCATION/LANGUAGES
Academic Degree (Bsc.) in Natural Sciences or Engineering (Chemistry, Biochemistry, Biotechnology or Microbiology).
English: Technical (read/written/spoken)

PROFESSIONAL SKILLS & EXPERIENCE

Previous industrial experience in ISO 13485 is an advantage.
Previous experience in a computerized environment.
Proficient Microsoft Office applications including Word, Power Point and Excel.

PERSONAL SKILLS & COMPETENCIES

Energetic and able to work in dynamic environments.
Strong problem solving and analytical skills.
Fluency in both written and spoken English.
Excellent communication skills
Good ability to work in teams
Multitasking and time management abilities
Detail oriented, excellent organizational and planning skills.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!